Devices and methods for delivery of expandable prostheses

ABSTRACT

The present disclosure provides a variety of prostheses, delivery systems and techniques to facilitate closure of transvascular or transcameral access ports. Various embodiments of prostheses are provided including a plurality of radially expandable discs that can be filled with material to facilitate coagulation and to reduce or stop leakage from punctures in vessel walls.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation of and claims the benefit ofpriority to U.S. patent application Ser. No. 16/049,946, filed Jul. 30,2018, which in turn claims the benefit of priority to and is acontinuation of U.S. patent application Ser. No. 15/664,642, filed Jul.31, 2017, issued as U.S. Pat. No. 10,045,765 on Jun. 14, 2018, which inturn is a continuation-in-part of and claims the benefit of priority toInternational Application No. PCT/US2017/029094, filed Apr. 24, 2017,which in turn claims benefit of U.S. Provisional Patent Application Ser.No. 62/326,710 filed Apr. 23, 2016.

This patent application is a continuation of and claims the benefit ofpriority to U.S. patent application Ser. No. 16/049,946, filed Jul. 30,2018, which in turn claims the benefit of priority to and is acontinuation of U.S. patent application Ser. No. 15/664,642, filed Jul.31, 2017, which in turn is a continuation-in-part of and claims thebenefit of priority to International Application No. PCT/US2017/029094,filed Apr. 24, 2017, which in turn is also a continuation-in-part ofU.S. patent application Ser. No. 15/277,798 filed Sep. 27, 2016, whichin turn is a continuation-in-part of and claims the benefit of priorityto International Application No. PCT/US2015/022782, designating theUnited States of America, filed Mar. 26, 2015, which in turn claims thebenefit of priority to U.S. Provisional Patent Application Ser. No.61/971,458, filed Mar. 27, 2014 and U.S. Provisional Patent ApplicationSer. No. 62/083,192, filed Nov. 22, 2014.

Each of the foregoing patent applications is incorporated by referenceherein in its entirety for any purpose whatsoever.

FEDERALLY-SPONSORED RESEARCH AND DEVELOPMENT

This invention was made with Government support under contract no.268201500012C awarded by the National Institutes of Health. The U.S.Government has certain rights in the invention.

BACKGROUND Field of the Disclosure

The present disclosure relates to a device and method for transcathetercorrection of cardiovascular abnormalities, such as the delivery ofprosthetic valves to the heart. The present disclosure further relatesto implants for closing a caval-aortic iatrogenic fistula created by theintroduction of a transcatheter device from the inferior vena cava intothe abdominal aorta.

Description of Related Art

Transcatheter procedures have been a milestone advance in modernmedicine. Percutaneous or transthoracic catheters are advanced throughthe vascular system or other natural luminal orifices to effectmechanical remodeling through angioplasty or to effect occlusion orpatency or valvular function through implants of self-expanding orballoon-expanding occluders, stents, and valves. These procedures cantake the place of surgical repair in selected patients.

Percutaneous vascular occluders are limited because usually they requirethe operator to forego guidewire access between target chambers. Recentinnovations permit vascular occluders to be engineered around a centralguidewire lumen to enhance safety and versatility of the occluderprocedure.

Recently, Halabi and colleagues (JACC 2013; 61:1745), and thereafterGreenbaum and colleagues (Transcatheter therapeutics conference, SanFrancisco, 2013) reported a novel procedure to introduce large vasculardevices into the aorta from the adjoining inferior vena cava. Thisenabled transcatheter aortic valve replacement in patients otherwiseineligible because of no surgical access to the thorax and insufficientiliofemoral artery caliber. The “caval-aortic” access port, as it iscalled, was closed using nitinol occluder devices marketed by St JudeMedical (Amplatzer® muscular ventricular septal defect occluder orAmplatzer® duct occluder) to close congenital cardiovascular defects.These devices are inadequately hemostatic, do not allow uninterruptedguidewire access, and are imperfectly suited for this application.

Transcatheter structural left heart procedures are generally performedthrough the femoral artery. However, femoral artery caliber orintravascular disease precludes or complicates vascular access in asignificant minority of candidates for transcatheter aortic valvereplacement or aortic endograft therapy. Moreover, the most frequentlife-threatening complication of TAVR is vascular complications of largeintroducer sheaths placed in the femoral artery. Alternativetranscatheter approaches to the heart would therefore be desirable. Thepresent disclosure provides solutions for these and other problems asdescribed herein.

SUMMARY OF THE DISCLOSURE

The purpose and advantages of the present disclosure will be set forthin and become apparent from the description that follows. Additionaladvantages of the disclosed embodiments will be realized and attained bythe methods and systems particularly pointed out in the writtendescription hereof, as well as from the appended drawings.

To achieve these and other advantages and in accordance with the purposeof the disclosure, as embodied herein, in one aspect, the disclosureincludes embodiments that solve problems of caval aortic access based onconsiderable pre-clinical, animal, imaging, and clinical experience incaval-aortic access. These approaches differ substantially from theaforementioned prior art.

In certain embodiments, the problem of variable distance between aorticand caval access points is solved using a telescopic design as disclosedherein. The problem of inadequate hemostasis of aortic and caval accesstracts, in some implementations, is solved using “billowing” nitinolweave to fill the vascular holes and by using multiple disks to occludeeach vascular rent.

In some implementations, a prosthesis is provided having a proximal endand a distal end, the prosthesis having a radially expandable body, theradially expandable body being configured to expand into at least onedistal disc after becoming unconstrained. The at least one distal discincludes a radially outwardly extending paddle attached to the at leastone distal disc. The paddle is configured to assume a radial orientationas the at least one disc expands outwardly radially. The paddle isconfigured to extend radially outwardly beyond an outer circumferentialperimeter of the at least one disc. The paddle is preferably configuredand arranged to facilitate confirmation of a location of a hole in alumenal wall in which the prosthesis is positioned by helping to seatthe prosthesis in the hole when the prosthesis is attached to a deliverycatheter, and to provide resistance to help prevent the prosthesis frombeing pulled through the hole.

In some implementations, the at least one distal disc is formed from abraided mesh body formed from a plurality of filaments that can slideacross one another during expansion. The at least one distal discdefines a volume therein. The prosthesis can further include a resilientmember distinct from the braided mesh body, the resilient member beingattached to a proximal region and a distal region of the prosthesisalong an axis that defines a central region of the prosthesis. Theresilient member is preferably configured to cause the prosthesis toshorten along the axis and expand radially when the resilient member isrelaxed. The resilient member and paddle preferably cooperate to preventthe prosthesis from being pulled through a hole formed in a wall of abody lumen.

If desired, the prosthesis can further include at least one radiallyexpandable proximal disc connected to the resilient member. Theresilient member can cause the at least one radially expandable proximaldisc and a neck region of the prosthesis separating the discs to bothexpand radially outwardly when the resilient member is unconstrained andpermitted to shorten axially. In some embodiments, the prosthesis canfurther include an outer annular fabric section extending between andjoining the at least one distal disc and the at least one radiallyexpandable proximal disc. The outer annular fabric section can beconfigured to surround a portion of the resilient member disposedbetween the at least one distal disc and the at least one radiallyexpandable proximal disc. In some implementations, the outer fabric canextend to the full radial extent of an inwardly facing face of each ofsaid discs.

In some implementations, the paddle can include a wire structural framethat is covered with fabric material that is configured to enhancetissue ingrowth into the paddle, wherein the fabric material is disposedat least on a face of the paddle that faces proximally when deployed soas to face a vessel wall when implanted to facilitate tissue ingrowthinto the paddle. If desired, the prosthesis can include a materialdisposed within the mesh body that is configured to encourage hemostasiswhen exposed to blood. The prosthesis can include at least oneradiopaque marker disposed proximate a proximally facing reduceddiameter portion of the at least one distal disc configured to reside inan opening in a vessel wall that is to be occluded by the prosthesis.The radiopaque marker can thusly be positioned so as to be located atthe opening in the vessel wall to indicate to a physician that theprosthesis is positioned correctly within the opening in the vesselwall, wherein the radiopaque marker is positioned proximate a surface ofa necked down section of the prosthesis that is located proximally withrespect to the at least one distal disc. For example, the radiopaquemarker can be located on a radially inwardly disposed portion of thepaddle.

In some implementations, the prosthesis can further include at least onelength limiting tether connecting the at least one braided distal discto a proximal portion of the prosthesis (such as to a proximally locateddisc of the prosthesis), the at least one length limiting tether ispreferably configured and arranged to prevent the resilient member fromstretching beyond a predetermined length.

The disclosure further provides embodiments of a system for deliveringprostheses as disclosed herein. An illustrative system includes an outertubular sheath having a proximal end and a distal end and defining afirst lumen therethrough along at least a portion of its length, thedistal end of the outer tubular member being cut at an angle that isoblique with respect to a central axis defined by the system, and thedistal end further including a radiopaque marker proximate the distalend making the angle at which the distal end is cut being visible underfluoroscopy to help reduce canting of the prosthesis duringimplantation. The system further includes an intermediate tubular memberdisposed at least partially within the first lumen and being slidablydisposed with respect to the outer tubular sheath, the intermediatetubular member having a proximal end, a distal end, and, a flexibledistal portion configured to be protrudable distally beyond the distalend of the outer tubular sheath, the intermediate tubular memberdefining a second lumen therethrough along at least a part of itslength, the flexibility of distal portion of the intermediate tubularmember being configured and adapted to permit the intermediate tubularmember to be deformed into a reverse curved geometry with respect to acentral axis of a proximal portion of the delivery system while inside apatient's lumen, wherein the reverse curved geometry can resemble aquestion mark. The system further includes an inner elongate memberbeing disposed at least partially within the second lumen, the innerelongate member being slidably disposed with respect to the intermediatetubular member, the inner elongate member having a proximal end and adistal end configured to be displaced distally beyond the distal end ofthe intermediate tubular member, wherein the inner elongate member is atubular member configured to permit a guidewire to pass therethrough. Adistal end of the inner elongate member can be configured to abutagainst an inner face of an end region of the prosthesis to form aguidewire lumen to permit the guidewire passing through the innerelongate member to pass through a distal face of the prosthesis. Thesystem can be provided with any prosthesis disclosed herein, removablymounted on the distal end of the intermediate tubular member, whereinthe prosthesis can be longitudinally stretched by advancing the innerelongate member distally with respect to the intermediate tubular memberand against the inner face of the end region of the prosthesis, andfurther wherein said longitudinal stretch of said prosthesis causes theprosthesis to collapse radially inwardly to permit said prosthesis to bewithdrawn into said distal end of said outer tubular sheath.

If desired, the resilient member of the prosthesis can be a coil springthat causes the prosthesis to collapse axially and the discs to expandradially to prevent the prosthesis from being pulled axially through ananatomical opening it has been delivered through after it has beendeployed. Preferably, the system is configured and arranged to cause thepaddle of the prosthesis to be urged against an inner wall of a lumenadjacent an opening in the lumen in which a portion of the prosthesis issituated to cause the at least one distal disc to come into parallelalignment with the inner wall of the lumen and prevent the at least onedistal disc from becoming canted in the lumen when said intermediatetubular member is bent into the reverse curved geometry.

The system further provides an axially telescoping prosthesis thatincludes a plurality of discrete radially expandable braided meshbodies, each of said bodies being formed from a plurality of filamentsthat can slide across one another, each of the braided mesh bodies beingconfigured to self-expand into at least one disc, each radiallyexpandable braided mesh body defining a volume therein, the plurality ofmesh bodies being axially displaceable with respect to one another. Theprosthesis further includes a resilient member structurally distinctfrom the plurality of discrete mesh bodies and passing through a centralregion of the mesh bodies configured and arranged to connect theplurality of discrete radially expandable braided mesh bodies to eachother, wherein (i) the radially expandable braided mesh bodies areselectively telescopically displaceable from one another along a centrallongitudinal axis of the prosthesis by stretching or relaxing theresilient member to accommodate differently sized anatomies, (ii) theresilient member is substantially co-axial with the central longitudinalaxis of the prosthesis, and (iii) the resilient member is configured tocause the prosthesis to shorten along the axis and expand radially whenthe resilient member is relaxed.

The prosthesis can further include at least one length limiting tetherattaching the plurality of discrete radially expandable braided meshbodies to each other, the at least one length limiting tether acting toprevent the resilient member from elongating beyond a predeterminedlength. If desired, the prosthesis can further include (i) at least onefabric disc disposed within each of the radially expandable mesh bodies,and (ii) a tubular fabric portion attached to at least one of the fabricdiscs, the tubular fabric portion extending proximally into a neckregion of the prosthesis. The resilient member can be a coil springsurrounded by fabric that causes the prosthesis to collapse axially andthe radially expandable braided mesh bodies to expand radially toprevent the prosthesis from being pulled axially through an anatomicalopening it has been delivered through after it has been deployed. A neckregion of the prosthesis can span between the radially expandablebraided mesh bodies including the coil spring surrounded by the fabric,and the neck region can expand radially outwardly when the coil springis unconstrained to help achieve hemostasis.

If desired, the resilient member can be a tension coil spring. In someimplementations, the prosthesis can define a lumen along its lengththrough both discs along an axial centerline of the prosthesis. Thelumen can be configured and arranged to act as an adjustable shunthaving an adjustable length when the prosthesis is deployed to connecttwo lumens. If desired, various prostheses disclosed herein can beconfigured to seal at least one hole in one lumen.

The disclosure still further provides a prosthesis that includes aplurality of radially expandable braided mesh bodies connected by meshmaterial, each of said bodies being formed from a plurality of filamentsthat can slide across one another, each of the braided mesh bodies beingconfigured to self-expand into at least one disc, each radiallyexpandable braided mesh body defining a volume therein. The prosthesisfurther includes a resilient member structurally distinct from the meshmaterial connecting the plurality of radially expandable braided meshbodies, the radially expandable braided mesh bodies being spaced fromone another along a central longitudinal axis of the prosthesis, theresilient member being substantially co-axial with the centrallongitudinal axis of the prosthesis, and the resilient member beingconfigured to cause the prosthesis to shorten along the axis and for theplurality of radially expandable braided mesh bodies to expand radiallywhen the resilient member is relaxed. The prosthesis further includes anouter fabric covering connecting the plurality of radially expandablebraided mesh bodies, the outer fabric being disposed outside of thebraiding of the plurality of radially expandable braided mesh bodies.

In some implementations, the prosthesis can define a lumen along itslength through both discs along an axial centerline of the prosthesis.The lumen can be configured and arranged to act as an adjustable shunthaving an adjustable length when the prosthesis is deployed to connecttwo lumens. The outer fabric can be annularly shaped and be configuredto surround at least a portion of the resilient member disposed in aneck region of the prosthesis spanning between the radially expandablebraided mesh bodies. The fabric in the neck region can expand radiallyoutwardly when the resilient member is unconstrained to facilitate theachievement of hemostasis.

In some embodiments, the outer fabric extends between and connectsadjacent faces of the at least one disc formed by each of the pluralityof radially expandable braided mesh bodies. If desired, the prosthesiscan further include interior fabric disposed within each of theplurality of radially expandable braided mesh bodies. The interiorfabric can be substantially radially coextensive with each disc formedby each of the radially expandable braided mesh bodies.

The disclosure still further provides a prosthesis including a radiallyexpandable mesh body that is configured to self-expand into a pluralityof discs after becoming radially unconstrained, the radially expandablemesh body defining a volume therein when expanded, and at least onetether directed through a distal disc of said plurality of discsconfigured to cause the plurality of discs to collapse together axiallywhen tension is applied to the at least one tether.

In some implementations, the radially expandable mesh body is configuredto self-expand into at least two discs connected by a neck region afterbecoming radially unconstrained, a first disc of the two discs beingconfigured to mitigate high pressure leaks in an artery, and a seconddisc of the two discs being configured to mitigate low pressure leaksoriginating from a vein, and further wherein the neck region isconfigured to cooperate with the first and second discs to preventleakage from the artery and the vein, and further wherein applyingtension to said at least one tether also acts to pull at least one ofsaid discs against a vascular wall to prevent canting of the prosthesis.If desired, at least one of (i) the radially expandable mesh body and(ii) the at least one tether can be formed from radiopaque material topermit real time visualization of installation of the prosthesis andsaid axial collapse of said discs under fluoroscopy.

If desired, the aforementioned prosthesis can further include a couplinglocated at the proximal end of the prosthesis configured to be attachedto a delivery system. The coupling can be configured to permit inflationfluid to pass therethrough.

In a further embodiment, a prosthesis is provided as described hereinhaving a mesh body that is configured to self-expand into at least twodiscs connected by a neck region after becoming radially unconstrained.A first disc of the at least two discs can be configured to mitigateleaks, and a second disc of the at least two discs can be configured tocause appropriate positioning of the prosthesis in the presence ofcardiovascular motion. Such a prosthesis can be used, for example, toaddress high pressure leaks from an artery or a cardiac chamber. In someimplementations, such a prosthesis can be used to address a ventricularseptal defect (VSD) (i.e., a hole in the heart). This is a common heartdefect that's present at birth (congenital). The hole occurs in the wallthat separates the heart's lower chambers (septum) and allows blood topass from the left to the right side of the heart. The oxygen-rich bloodthen gets pumped back to the lungs instead of out to the body, causingthe heart to work harder. The prosthesis can be delivered and deployedinto the defect and deployed, sealing the hole.

In further embodiments, such a prosthesis can be used for varioustranscardiac applications, wherein the second disk assures retention inposition of the prosthesis. For example, such a prosthesis can be usedto seal an access opening through the aortic arch that is formed foraccessing the aortic valve after the valve is replaced. Similarly, suchan approach can be used to seal openings formed in lumenal or vascularwalls such as apical access procedures for sealing openings formedthrough the ventricular wall, for sealing openings formed in a septum(e.g., patent foramen ovale (PFO)) and the like.

Unique benefits of the disclosed prosthesis and delivery system includethat the prosthesis can be adjusted, or even removed after beinginstalled in a vascular opening, for any desired reason. Thus, in someembodiments, the disclosure provides a method that includes a deliverysystem as described herein including a prosthesis as disclosed hereinmounted thereon, delivering the delivery system over a guidewire routedto a target location, and fully deploying the prosthesis at the targetlocation to obstruct a vascular opening to be sealed. The prosthesis canthen be detached from the delivery system. The delivery system can thenbe withdrawn over the guidewire after the prosthesis has been detachedtherefrom. Then, if desired, the delivery system can be once againadvanced over the guidewire after withdrawing it, and the prosthesis canbe reattached to the delivery system. A further step can then beperformed with the prosthesis including at least one of: (i) partiallycollapsing the prosthesis, (ii) repositioning the prosthesis, and (iii)collapsing and withdrawing the prosthesis into the delivery system, andremoving the delivery system and prosthesis over the guidewire. Thedisclosed method is facilitated by the use of a pushrod (preferably atubular pushrod) as disclosed herein.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and are intended toprovide further explanation of the embodiments disclosed herein.

The accompanying drawings, which are incorporated in and constitute partof this specification, are included to illustrate and provide a furtherunderstanding of the method and system of the disclosure. Together withthe description, the drawings serve to explain the principles of thedisclosed embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects, aspects, features, and advantages ofexemplary embodiments will become more apparent and may be betterunderstood by referring to the following description taken inconjunction with the accompanying drawings, in which:

FIGS. 1A-1D depict a distal portion of an illustrative delivery systemfor delivery of a prosthesis for closure of transvascular ortranscameral access ports and the prosthesis itself.

FIGS. 2A-2D illustrate various aspects of the prosthesis delivered bythe device of FIG. 1.

FIG. 3A illustrates an embodiment of a further prosthesis in accordancewith the disclosure.

FIGS. 3B-3C illustrate examples of prior art prostheses.

FIGS. 4A-4C illustrate a further embodiment of an implantable device inaccordance with the disclosure mounted on the distal end of a deliverysystem.

FIG. 4D illustrates a further embodiment of an implantable device inaccordance with the disclosure.

FIGS. 5A-5C illustrate a prosthesis mounted on the distal end of adelivery system, showing articulation of the delivery cable shaft.

FIGS. 6A-6C illustrate variations of windings that can be used to helpform the prosthesis.

FIG. 7 illustrates a portion of a delivery system in accordance with thedisclosure without a prosthesis mounted thereon and with an outerportion of the system removed.

FIG. 8 is an illustration of an exemplary embodiments of a deliverysystem with a prosthesis mounted thereon.

FIGS. 9A and 9B illustrate a further adjustable, compliant,maneuverable, retrievable and repositionable four disc/lobe closuresystem.

FIGS. 10A-10B illustrate a three disc/lobe embodiment wherein a centraldisc is located between the aorta and inferior vena cava.

FIG. 11A-11B illustrate a four disc and three disc embodiment of aprosthesis.

FIG. 12A-12B illustrate the prosthesis in a deployed condition with theend disc flattened.

FIG. 13A-13B illustrate the prosthesis in a deployed condition with theend disc flattened.

FIG. 14A-14B illustrate the prosthesis and delivery catheter withtethers running through all four and three prosthesis and into a guidingsheath of the delivery catheter.

FIGS. 15A-15B and FIGS. 16A-16B illustrate a complete deployment of athree disc embodiment from beginning to end.

FIGS. 17A-22 present further illustrative embodiments of telescopicclosure prostheses in accordance with the disclosure and method of usethereof.

DETAILED DESCRIPTION

Reference will now be made in detail to the present preferredembodiments of the disclosure, examples of which are illustrated in theaccompanying drawings. The method and corresponding steps of thedisclosed embodiments will be described in conjunction with the detaileddescription of the system.

The exemplary embodiments illustrated herein can be used to moreeffectively close transvascular or transcameral access ports. Forpurposes of illustration, and not limitation, as embodied herein and asillustrated in FIG. 1, a delivery system 200 is provided includingprosthesis 100 mounted thereon. An illustration of a full exemplarysystem can be seen in each of FIG. 7 and FIG. 8, which are discussed infurther detail below.

As referred to herein, the term “prosthesis” is intended to refer to astructural element that may or not be resorbable in whole or in partthat can be used to replace a portion of anatomy and/or to close anopening in anatomy, particularly within the vasculature of thecardiovascular system. The prosthesis typically includes an adjustableframework or other body that can be used to close the openings invasculature.

As illustrated, the distal region of the system 200 includes a distalend of an outer tubular member 124 that can be introduced through alumen of a guiding catheter (not shown) that is used to deliver aprosthesis or perform some other function via a transvascular ortranscameral access port. The distal end of the outer tubular member 124is preferably provided with a distal radiopaque marker 120, such as onemade at least in part from silver, gold, platinum or other radiopaquematerial, as desired. The distal tip 122 of the outer tubular member canbe cut on a bevel and be provided with a marker that is aligned with thebevel near the beveled tip to facilitate guiding the device across thewall of the inferior vena cava into the aorta, for example. The bevelmay be at any suitable angle, but is preferably offset from a centralaxis of the catheter by an angle between about 30 degrees and aboutsixty degrees, or any angular increment therebetween of about onedegree. In an illustrative embodiment, the angle can be about 45degrees. It has been found that such beveling of the tip helps to reduce“canting” or undesirable tilting of the implant during installation asit permits alignment of the bevel and the wall of the vessel that itengages. It is also desirable in some embodiments to have a rotationalmarker that at the distal end of the prosthesis at a particularrotational position (such as at the end of the tapered cut at the veryend of the outer tubular member) that can be used to rotationally alignthe prosthesis when it is being collapsed and pulled into the distal endof the outer tubular member. The outer tubular member can be articulableor steerable at its distal end to facilitate maneuverability of thesystem. However, as discussed further below, the intermediate member 118is preferably flexible, and can help eliminate the need for a steerableouter tubular member.

Outer tubular member 124 may be made from a variety of materials. Forexample, the sheath 120 can include a multi-layered co-extrusion, suchas those described in U.S. Pat. No. 6,464,683 to Samuelson or U.S. Pat.No. 5,538,510 to Fontirroche. Each of the aforementioned patents isincorporated by reference herein in its entirety.

Any surface of various components of the catheters described herein orportions thereof can be provided with one or more suitable lubriciouscoatings to facilitate procedures by reduction of frictional forces.Such coatings can include, for example, hydrophobic materials such asPolytetrafluoroethylene (“PTFE”) or silicone oil, or hydrophiliccoatings such as Polyvinyl Pyrrolidone (“PVP”). Other coatings are alsopossible, including, echogenic materials, radiopaque materials andhydrogels, for example.

Within the outer tubular member 124 of the delivery system 200 a tubulardelivery cable, or intermediate tubular member 118, is slidably disposeddefining therethrough a central lumen along its length for slidablyreceiving a pushrod 180 therethrough, discussed in detail below. Adistal region of the intermediate tubular member 118 can be configuredto be of a lower stiffness, or durometer, than a proximal region of thecable to make it easier to articulate the distal end of the system, suchas embodiments wherein the outer tubular member 124 have an articulabledistal end or region. As illustrated, the intermediate tubular member118 terminates in a coupling 116 for attachment to the prosthesis 100.The illustrated coupling 116 is a female member that receives acorresponding male coupling portion 114 on the prosthesis 100, but itwill be appreciated that the coupling 116 on the delivery system can bemale and that the coupling on the prosthesis can be female. In someimplementations, a female coupling can be provided on the prosthesisthat is defined by the inside of a coiled member, discussed in furtherdetail below, that is received by a male threaded coupling on thedelivery system. The coupling may be a threaded coupling but can also bea twist and lock coupling or the like.

As further illustrated in FIGS. 1A-1B, a first exemplary embodiment of aprosthesis 100 is provided having a proximal end that connects to thedelivery system, and a distal end 104 through which a guidewire canextend via a guidewire lumen 106. As illustrated, the prosthesis 100includes an interior coil tension spring 101 that is configured to becontracted into a relaxed state when not being stretched. This resultsin the prosthesis being in a shortened, compressed state when relaxed.This is most evident in FIG. 1C, showing a compressed prosthesis 100when the tension spring 101 is in a relaxed, unelongated condition. Bystretching the coil spring, such as by pulling both ends of theprosthesis apart, the prosthesis takes on a more elongated profile witha smaller radial profile, such as depicted in FIGS. 1A or 2C.

The coil spring 101 can have a substantially uniform outer and innerdiameter along its length from a proximal end of the prosthesis to thedistal end of the prosthesis. Alternatively, as illustrated in FIGS. 6A,the coil spring 101 can have a first portion that has a larger diameterthan a second portion, wherein the smaller diameter portion can bedirected toward the proximal or distal end of the prosthesis. Asillustrated in FIG. 6B, the coil spring can have three regions ofdifferent diameters, wherein a central region of the coil spring canhave an enlarged diameter with respect to the diameter of either endportion. The end portions can be of the same or different diameters.Having an enlarged central portion can help prevent leakage after theprosthesis is installed as the coil can urge against the graft and/ormesh material within the adjustable neck 110 region of the deployedprosthesis between the lumens to cause the neck to bulge outwardlyagainst the outer lumen walls to facilitate sealing and to help preventleakage. The windings of the coil spring that is attached to the highpressure disc on the distal end of the prosthesis can be sized andshaped to prevent the hypotube from passing out of the distal end of theprosthesis, but to permit the guidewire to pass through. Similarly, theportion of the coil spring at the proximal end of the prosthesis thatfaces the delivery system can have a coil spring that is configured tobe threaded onto a male end of the intermediate tubular member 118 toattach the prosthesis to the delivery system.

It will be appreciated that while a coil spring is primarily illustratedherein and is preferred, other resilient or elastic members can be usedin place of the coil spring, or the prosthesis may instead be providedwith retractable tethers (discussed in detail below with respect toFIGS. 9 onward). For example, a single or a loop Elastic band that isattached to the radially expandable discs can be used, and/or anysuitable material that can act as a tension spring and have a suitablylow profile.

The prosthesis 100 further includes a mesh covering that may be braidedfrom a variety of materials such as NiTi alloys or bioresorbablematerials. It should be noted that, in some implementations, theprosthesis can be made from bioresorbable materials in its entirety.Suitable bioresorbable materials and techniques for construction can befound, for example, in U.S. patent application Ser. No. 11/398,363,filed Apr. 4, 2006, and U.S. patent application Ser. No. 14/461,159,filed Aug. 5, 2014, each of which is incorporated by reference herein inits entirety for any purpose whatsoever.

The mesh covering preferably defines at least one proximal lobe, or disc112 and at least one distal lobe, or disc 102 joined by a narrowed neck110 region that can be adjustable in radial dimension so as to permit acustom fit during implantation to minimize or eliminate leakage from theaorta and IVC. The mesh covering is joined at each of the proximal anddistal ends to the respective proximal and distal ends of the coilspring. If desired, the disc 102 can be a high pressure endolumenal discconfigured for placement against an inner arterial wall and disc 112 canbe a low pressure disc configured for placement, for example, against aninner wall of the inferior vena cava.

The interior of the mesh can be filled with a woven graft material 108and/or an elastomer with a coagulating coating, such as polyethyleneglycol (PEG), or other non-thrombogenic, bio-inert polymer or polymerprecursor.

For example, as illustrated in FIG. 1D, which presents a cross sectionof prosthesis 100, the distal face of the distal lobe or disc caninclude a first disc shape graft portion 108 a that has a continuoussurface except for a small hole or aperture 108 b at the center thereoffor surrounding the distal end of the coil spring 101 where it meets themesh to permit the guidewire to pass through the distal end of theprosthesis. This first disc shaped portion 108 a can be joined about itsouter periphery (e.g., by weaving or stitching) to a second disc shapedportion 108 c which also defines therein a central aperture 108 d whichmay be slightly larger than 108 b to permit passage therethrough of thecoil spring which in turn is sized and shaped to permit passagetherethrough of a pushrod (e.g., a stainless steel or NiTi hypotube, orpolymeric (e.g., PEEK) or composite (e.g., carbon fiber) tubular member)of the delivery system containing the guidewire (discussed below). Afurther tubular graft portion 108 e can be attached to and depend in aproximal direction from the proximal face of second disc shaped portion108 c to line the neck region of the prosthesis 100 and to surround thecentral region of the coil spring 101. If desired, portion 108 e can bestitched at one or more locations to the mesh structure. In someimplementations, the graft material 108 can still further include athird disc-shaped portion 108 f attached to the proximal end of tubularportion 108 e also defining a central aperture therein 108 g forpermitting passage of the coil 101. Disc 108 f can similarly be joinedabout its periphery via weaving or stitching to a fourth, proximal disc108 h defining therein a central aperture 108 i, which in turn surroundsthe proximal end of the spring where it meets the proximal portion ofthe mesh to seal around the spring. The outer periphery of the fouraforementioned discs may be stitched to each other and to the mesh toensure proper registration of the mesh with the graft material.

As further illustrated in FIG. 1C, a pushrod 180 is slidably disposedwithin the lumen of the intermediate tubular member 118. The pushrodincludes a proximal end attached to an articulable proximal handle (seee.g., FIGS. 7 and 8) and a distal end that abuts an inner surface of thedistal end portion of the prosthesis 100. Specifically, the distalcentral opening of prosthesis 100 is large enough to permit a guidewireto pass therethrough, such as between 0.010 and 0.060 inches or othersuitable diameter. Preferably, the aperture is small enough for thedistal end of the pushrod 180, which defines a central lumen to slidablyhouse the guidewire, to not pass through the opening, and instead urgeagainst the inner distal surface of the prosthesis. Instead, the distalend of the pushrod (or push tube, as desired), abuts an inner distalsurface of the prosthesis at or near the location of the opening. Forexample, the inner distal surface of the prosthesis can define ashoulder about the opening that the push rod pushes against, or ifdesired, the windings of spring 101 can be such that the most distalwindings permit the guidewire to pass through, but not the push rod/pushtube.

FIG. 2A is a schematic cross sectional representation of the prosthesis100 in an extended or longitudinally stretched state wherein the coilspring 101 is in a stretched condition, and FIG. 2B illustrates theprosthesis in a relaxed condition in situ after installation grippingboth sides of a lumenal passage. FIG. 2C similarly depicts an outer viewof a prototype prosthesis 100 in an expanded condition wherein the pushrod/push tube is urged distally within the delivery system (not shown)against the distal end of the prosthesis to cause the coil spring tostretch longitudinally. FIG. 2D illustrates the same prosthesis in arelaxed condition after the push rod/push tube is withdrawn. As can beappreciated, the coil spring 101 forces each of the lobes or discsincluding the exterior mesh with graft material inside to flatten andbetter contact the wall of the vessel (or chamber, depending on theapplication) and thereby better achieve hemostasis.

FIG. 3 illustrates relative performance between a disclosed embodimentand prior art embodiment. For example, an exemplary embodiment having afirst disc section constructed as described above is presented in FIG.3a . This embodiment resists pull-through the lumenal or chamber wallbecause the spring, or elastic member, is attached to the center of thedistal or “high-pressure” disk (that could be located within an artery,for example), which causes the distal disk to flatten. Prior artembodiments (FIGS. 3B & 3C), such as Amplatzer Duct Occluder product,does not have such an elastic member or spring, and therefore assumes anoblong configuration during the retraction phase of deployment (arrow)and therefore is susceptible to inadvertent pull-through, whichnaturally leads to a potentially dangerous situation for the patient.

FIGS. 4A-4C illustrate a further embodiment of a prosthesis that, inaddition to having all of the aforementioned structural features,additionally include additional elongate radially oriented struts or“wings” 136, 138 that are attached to the mesh of the prosthesis at thedistal and proximal faces of the prosthesis, extending from a radiallycentral portion of the prosthesis to an outer periphery of theprosthesis. These struts enhance the collapsibility of the prosthesisunder the action of the spring or elastic member. While these wings orstruts can be constructed as loops, they can be made in any desirable orsuitable manner. FIG. 4A illustrates such a prosthesis in alongitudinally expanded configuration wherein the mesh envelope isstretched longitudinally over the graft material and spring, whereasFIG. 4B illustrates the prosthesis in a relaxed condition wherein it canseal against one or more lumenal walls. FIG. 4C further illustrates theprosthesis in a fully longitudinally expanded configuration wherein thepush rod/push tube is fully extended causing the prosthesis to collapseradially inwardly so that it can be inserted into a delivery sheath.Significantly, this design permits the device to be retrieved andremoved, or removed and repositioned and reimplanted and moved asdesired. In other words, the combination of the elastic member or springand delivery system with a push rod or push tube greatly enhancesdeliverability and placement of the prosthesis.

FIG. 4D illustrates an alternative embodiment of a prosthesis 140 thatincludes a main body formed from an inflatable, preferably bioresorbablematerial that is configured to seal a transcameral or transvascularaccess port, or other anatomical opening to be sealed. As illustrated,the prosthesis 140 has a proximal end attached to coupling 114 that inturn is removably attached to a coupling 116 located at the distal endof the intermediate tubular member 118. A lumen (not visible) passingthrough member 118 can carry fluid therethrough for inflating prosthesis140 during delivery. Fluids, such as biodegradable polymer, resin orsaline can be used to inflate prosthesis 140.

Fluid ports (not visible) can be provided in each of members 114, 116 tofacilitate the inflation. Optionally, a guidewire port 106 canadditionally be included. Wings 136, 138 can also be included to holdagainst the interior surfaces of the aorta and inferior vena cava, forexample, while the inflatable body of the prosthesis 140 spans the gapbetween the two vessels and protrudes slightly into each vessel. Theprosthesis 140 can be radially compressed within the distal end of outertubular member 124 as with prosthesis 100. The compressed prosthesis 140can be delivered to the site at which it is to be implanted, and thewings 136 can be deployed inside the aorta, for example, or other firstlocation. The outer tubular member/sheath 124 can be retractedproximally thereby exposing the entire prosthesis 140 to the surroundinganatomy. A fluid actuator (e.g., fluid plunger that is actuated linearlyor rotationally with a rotating handle driving screw) can then bedepressed/actuated causing inflation fluid to be directed through thedelivery system and into the prosthesis 140. The prosthesis 140 can beinflated to a desired extent to block leakage, and the wings 138 can bedeployed (before, during or after inflation), causing the prosthesis tobe lodged within the desired location. The wings/struts 136/138 could bewire loops that pass through the body of prosthesis, or can be mountedon either end of the prosthesis 140. Wings 136/138 are preferably shapedso they can be easily collapsed and retrieved into the delivery system.

If it is desired to move or remove the prosthesis 140, the fluid can beevacuated from the prosthesis by moving the fluid actuator in theopposing direction. The prosthesis can then be repositioned andimplanted, or withdrawn into the distal end of outer tubular member 124,as desired. If desired, a push rod or push tube can be used to assist inretrievability of the prosthesis 100.

FIGS. 5A-5C further illustrate an embodiment of the prosthesis in acollapsed state on a delivery system in various articulated/steeredpositions allowing for adapting to the oblique angle of the devicenecessary for deployment and final release of the device.

FIG. 7 is an end to end illustration of a portion of an example ofdelivery system in accordance with the disclosure without the prosthesismounted thereon and with the outer tubular member removed. As can beseen in FIGS. 7 and 8, the device itself, as well as the outer tubularmember, intermediate tubular member, and push rod or push tube each haveproximal end attached to a handle or control knob and a distal end. Theintermediate tubular member as illustrated in FIG. 7 includes arelatively stiff proximal portion attached to a back end 150, and atransition segment 148 that is in turn attached to a distal flexiblesegment that terminates in coupling 116.

As illustrated in FIG. 8, the outer tubular member 124, or main deliverycatheter, includes a back end 160 including a handle and steering knobconfigured to articulate the distal end of main delivery catheter/outertubular member 124 that is attached to a proximal tubular region whichin turn is connected to a distal tubular region terminating in beveledtip 122 that preferably also includes a marker that tracks the bevel tofacilitate installation and reduce canting, or tilting, of theprosthesis during installation. The actuator 160 can take on a varietyof forms, such as those depicted in U.S. Pat. No. 6,488,694 to Lau andU.S. Pat. No. 5,906,619 to Olson, the specifications of which areincorporated herein by reference in their entireties.

Before the system is introduced into the patient via a guiding catheter(not shown), the push rod 180 is fully distally extended to radiallycollapse the prosthesis, after which the intermediate tubular member canbe withdrawn into the distal end of the main delivery catheter 124. Theintermediate tubular member 118, or delivery cable shaft, thuspreferably has variable stiffness along its length with a softer distalsegment allowing for adapting to the oblique angle of the devicenecessary for deployment and final release of the device. If a paddle asdiscussed herein is provided on the prosthesis, the paddle, or otherportion of the prosthesis can be radially aligned with respect to theouter tubular sheath, such as with respect to a marker, such as aradiopaque marker, provided in a selected rotational location on (at ornear) the end of the outer tubular sheath.

However, the present disclosure provides additional embodiments. Forexample, if desired, the prosthesis can be provided with more than twodiscs or lobes.

For purposes of illustration, and not limitation, FIGS. 9A and 9Billustrate a further adjustable, compliant, maneuverable, retrievableand repositionable four disc/lobe closure system that resembles the twolobe system discussed above, except that two additional discs or lobesare provided between the proximal and distal lobes. While the discs aredepicted as being formed from a NiTi alloy, it will be appreciated thatany suitable material can be used.

As illustrated in FIGS. 9A and 9B, in an installed formation, theprosthesis includes a first high pressure or artery facing disc 16 thatis deployed in the aorta, for example. The caval wall 4 and arterialwall 2 are presented with the prosthesis mounted therein. A nextproximal disc 12 is provided for deployment against the outer wall ofthe aorta. A marker band 6 is also provided to enhance retention of theprosthesis. A third external caval disc 10 is provided for urgingagainst the exterior of the inferior vena cava, and a fourth disc 8 isprovided to seat within the IVC. One or more of the four discs can beprovided with an exterior curvature or taper 14 that facilitatessealing, and all four discs can be formed from a mesh as with embodiment100. A spring need not be located within the prosthesis of FIG. 9, butit can be. Collapsing of the prosthesis can be facilitated with tethers62 that run through all four and three prosthesis and into a guidingsheath 64 of the delivery catheter as illustrated in FIG. 14A-B. Asillustrated in FIGS. 16A-B, the tethers can be withdrawn and pulled andthe delivery catheter can be held fast to tighten the tethers until allleaks are stopped. The tethers can then be tied off or clipped, and thedelivery system can be removed accordingly.

FIG. 9A shows the prosthesis after deployment but before the tethers arecinched, while FIG. 9B shows the tethers after cinching. FIGS. 10A-Bsimilarly show a three disc/lobe embodiment wherein a central disc 28 islocated between the aorta and inferior vena cava. The construction isotherwise the same as the embodiment of FIG. 9, and may be constructedwith an interior spring if desired as with embodiment 100 if desired,and/or can be provided with tethers as the embodiment of FIGS. 9A-9B.The embodiment of FIGS. 10A-B may also be provided with a guidewirelumen 30.

FIG. 11A depicts a four disc embodiment of a prosthesis wherein aradiopaque and/or elastomer covered neck 36 is provided between the highpressure disc 38 and the second disc 12, wherein the elastomer 34 isdesigned to help prevent leakage. Also visible are the low pressurecaval disc 40 and third disc 10, wherein discs 10, 12 and 40 each haveradiopaque markers disposed therebetween. FIG. 12A shows the prosthesisin a deployed position wherein the end discs are flattened and themiddle discs are not fully flattened. FIG. 11B similarly provides athree disc version wherein like reference numbers indicate likestructures.

FIGS. 12A illustrates a four disc embodiment in a deployed conditionwherein the caval disc 50 and aortic disc 52 are compressed and fixed,and the intermediate discs 10, 12 are expanded to express a taper 14 tofacilitate sealing and prevent leakage. FIG. 12B illustrates a threelobed prosthesis wherein the caval 52 and aortic 50 discs are fullydeployed and flattened, and further wherein the central disc 28 isdeployed to define a tapered sealing surface 14. FIGS. 13A-B show afurther variant of a four disc embodiment in a semi deployed conditionand in a simulated installed condition in anatomy.

FIGS. 14A-14B illustrate four and three disc prosthesis embodimentsrespectively with tethers 62 routed through them, wherein the aorticdisc 16 is located at a distal end of the assembly, and a most proximatedisc 8 is also provided. The tethers 62 are directed through theprosthesis, and then proximally through a tubular member, or tetherlumen 64, toward the proximal end of the delivery system 68 through aport and/or handle 66. A handle 70 is further provided that is attachedto an elongated member or closure holding shaft 72 (e.g., tube or rod)that is attached to the prosthesis via a removable coupling, such as aholding, releasing and/or retrieval articulating screw with wire lumen.FIGS. 15-16 show a complete deployment of a three disc embodiment frombeginning to end.

FIGS. 17-19 present a further illustrative embodiment of a telescopicclosure prosthesis in accordance with the disclosure. The prosthesis canbe delivered using the delivery catheter described herein above.

FIGS. 17A-17E illustrate particular structural aspects of the prosthesis1700. As illustrated, prosthesis 1700 includes a distal disc 1702 and aproximal disc 1712 as with preceding prostheses described herein,connected by a tension coil spring 1701. However, prosthesis 1700differs quite significantly in structure from any of the foregoingprostheses described herein. In pertinent part, although the discs 1702,1712 are formed of a braided material, they are not connected by braidedmaterial, but are instead connected by the spring 1701, as well as theillustrated expansion limiting tethers 1736, 1738, or the disclosedouter fabric covering. Prosthesis 1700 is presented in a compacted form,as illustrated in FIG. 17D wherein the tension spring 1701 has fullycollapsed the device axially. FIG. 17E, in contrast, illustrates theprosthesis 1700 in an axially expanded format.

Disc 1702 is also provided with a further structure, or “paddle” thatextends radially outwardly from the disc 1702 when deployed that ispreferably covered by fabric that is configured to cause tissue ingrowththerein. The paddle can be attached to the structure of the inner faceof disc 1702 such that its orientation is parallel to a longitudinalaxis of the delivery system when the prosthesis 1700 is collapsed. Sincethe paddle is attached to the planar inner face of disc 1702, it thenreorients to being generally transverse, or even perpendicular, to thelongitudinal axis of the delivery system when deployed. If desired, thepaddle can be attached to any face of the prosthesis 1700, depending onhow it is being delivered. Moreover, multiple paddles can be providedattached to the same or different discs. In one embodiment, two paddlesare attached to the proximal face of the distal disc rather than one asillustrated that are positioned at the same general circumferentiallocation of the disc (next to each other) or spaced apart from eachother, such as by 180 degrees. In another embodiment, three or more(e.g., four five) paddles are provided that may be spaced from eachother circumferentially uniformly or non-uniformly.

The paddle can be a wire frame as depicted and may be partially orcompletely covered by synthetic or living tissue or graft material, ormay be uncovered. In the illustrated embodiment, a polyethyleneterephthalate (“PET”) fabric is used. Generally, with respect toprosthesis, fabric provided within the mesh discs (e.g., 1702) is madefrom a polyester with a non-stretchable weave, such as a braidedpolyester material. The material serves to reduce or prevent the flow ofblood across the disc 1702. The fabric is preferably between about 0.003to about 0.004 inches thick, and more generally can range from about0.0005 to about 0.010 inches thick, or any increment therebetween of0.0001 inches, as desired.

The outer fabric that resides over the neck region of the prosthesis1700 extending over the proximal face of the disc 1702 and proximallyover the neck of the prosthesis, for example, is preferably a knittedpolyester and has conformability to the shape of the disc. Although thismaterial is knitted and defines pores therein, it facilitateshemostasis, preferably immediate hemostasis, when disc 1702 is deployed.The material is also suitably configured to facilitate tissue ingrowthafter implantation of the prosthesis. The outer fabric is preferablyabout 0.009 inches thick, and more generally can range from about 0.002to about 0.010 inches thick, or any increment therebetween of 0.001inches, as desired.

In use, the paddle provides pullout resistance when the prosthesis isdeployed, but also helps a physician locate the hole in the lumen (e.g.,artery) due to the geometry of the paddle and prosthesis. Specifically,during delivery of the prosthesis, significant force is exerted by theprosthesis against the inner arterial wall above the opening throughwhich the prosthesis extends. The paddle extends upwardly above theopening in the artery parallel to the direction of the artery (i.e., inthe cranial direction). When the prosthesis is pulled on by the deliverysystem, the paddle is urged against the arterial wall above the hall,and prevents the prosthesis from being pulled out of the artery, but thepaddle also acts as a fulcrum, and causes the prosthesis to rotate aboutthe tip of the paddle, pulling the opposing end of the disc intoalignment with the vessel wall to prevent canting, and enhancealignment. This is done in cooperation of the reverse curveconfiguration that the intermediate tubular member of the deliverysystem can assume, which pulls the prosthesis “up” and into anorthogonal relationship with the vessel (e.g., artery).

As can be appreciated from the figures, distal disc 1702 is configuredfor placement in an arterial environment, wherein graft material isdisposed in the disc in a manner similar to the embodiment of FIG. 1Cherein. Specifically, the distal face of the distal disc 1702 caninclude a first disc shape graft portion 1708 a that has a continuoussurface except for a small hole or aperture 1708 b at the center thereoffor surrounding the distal end of the coil spring 1701 where it meetsthe mesh to permit a guidewire to pass through the distal end of theprosthesis. This first disc shaped portion 1708 a can be joined aboutits outer periphery (e.g., by weaving or stitching) to a second discshaped portion 1708 c which also defines therein a central aperture 1708d which may be slightly larger than 1708 b to permit passagetherethrough of the coil spring 1701 which in turn is sized and shapedto permit passage therethrough of a pushrod (e.g., a stainless steel orNiTi hypotube, or polymeric (e.g., PEEK) or composite (e.g., carbonfiber) tubular member) of the delivery system containing the guidewire,as with the embodiment of FIG. 1. A further tubular graft portion 1708 ecan be attached to and depend in a proximal direction from the proximalface of second disc shaped portion 1708 c to line a neck region of thedistal disc 1702 and to surround a portion of the coil spring 1701. Incontrast to the embodiment of FIG. 1, distal disc 1702 of prosthesis1700 further includes a concave graft portion 1708 f defining anaperture 1708 g in a center thereof to accommodate the coil spring 1701,as well as a distal floating sleeve or marker band 1732 that isconfigured to slide over an outer surface of the coil spring 1701 whenthe spring expands, whereas the distal face of disc 1702 is attached atits central region to the coil spring 1701.

The graft portions 1708 a, 1708 c, 1708 e, 1708 f cooperate with theexterior surface of the spring 1701 to define an interior compartment1709 that can be used for a variety of purposes. For example,compartment 1709 can be used to include a beneficial agent, such as acoagulating gel, or other beneficial agent such as a pharmaceuticalcompound or other material. The concavity defined on the distal disc1702 permits the sleeve 1734 of the proximal disc to be nested withinthe mesh of the distal disc, thus permitting a very compactconfiguration if needed. Instead of or in addition to a woven graftmaterial, an elastic polymer and/or a hydrophilic polymer layer can besued to enhance closure and placement of prosthesis 1700, especially ina calcified fistula.

Proximal disc 1712 is similar in many respects to disc 112 of theembodiment of FIG. 1, except that it is not attached to the distal disc1712 at its distal end, and is instead attached to a proximal floatingsleeve or marker band 1734 that is configured to slide over an outersurface of spring 1701, as with distal floating sleeve or marker band1732. Discs 1702, 1712 are illustrated as being connected atsleeve/marker bands 1734, 1732 by way of expansion limiter tethers 1736,1738. The net result is that when the prosthesis 1700 is expandedaxially as illustrated in FIGS. 17A, 17E, the discs 1702, 1712 maintaina relaxed condition as when deployed fully until the expansion limitertethers 1736, 1738 begin to be placed under tension. When expansionlimiter tethers 1736, 1738 are placed under tension, the discs 1702,1712 will deform by decreasing in radial dimension, which can be usefulwhen loading the prosthesis 1700 into a delivery sheath as describedherein, or if it is desired to remove the prosthesis and reposition itin situ during the procedure. Expansion limiter tethers 1736, 1738further act to prevent the coil spring 1701 from being overly stretchedor yielded (e.g., deformed plastically), and can also act to hold theprosthesis 1700 together in the event that spring 1701 fractures.

Prosthesis 1700 provided additional advantages as compared to the otherprostheses described above. By virtue of the inner ends of the discs1702 and 1712 being able to freely slide over the coil tension spring1701 independently of each other, it is possible to have a trulytelescoping prosthesis. This permits the discs 1702, 1712 to be in anoptimal configuration when installed, yet allow for different distancesbetween the discs 1702, 1712, thus permitting a prosthesis 1700 of thesame design to be used in multiple patients having larger or smallerdistances between adjacent lumens that incorporate the prosthesis 1700.Further, the discs 1702, 1712 of prosthesis 1700 can be made in whole orin part from bioresorbable material metallic or polymeric materials.

In addition to providing true telescoping ability, decoupling the discs1702, 1712 from each other greatly facilitates articulation of theprosthesis. As seen in FIG. 18, the distal disc 1702 can easily bearticulated with respect to the proximal disc 1712, by an angle that isalmost 90 degrees (e.g., 60, 70, 80 degrees). If desired, a backend pushrod extension limiter 1780, such as in the form of a bushing over theshaft of the delivery catheter (FIG. 17F) can be provided to avoidoverly stretching the prosthesis axially.

The delivery system can be used to collapse discs for loading, fullretrieval even after full deployment and individual control of discs.For example, as illustrated in FIG. 19A, an implant is loaded within thedelivery system and delivered to a target site for deployment. Thedistal disc 1702 is then advanced from the catheter into an artery, forexample, as illustrated in FIG. 19B. FIG. 19C illustrates the distalaortic disc 1702 fully deployed, and preparing it to be seated. FIG. 19Dillustrates axial extension of spring 1701, by pushing on pushrod 180.The proximal venous disc 1712 is then deployed as shown in FIG. 19E.FIG. 19F illustrates the proximal venous disc 1712 in a fully deployedcondition to be seated. FIG. 19G illustrates releasing the prosthesis1700 from the delivery system, which can then be removed, as illustratedin FIG. 19H. It will be appreciated that the prosthesis of FIG. 19 isnot illustrated as having the paddle shown in other figures, but apaddle can be provided on the prosthesis if desired.

FIG. 20 illustrates further aspects of the prosthesis and deliverysystem, showing the advantages of using the paddle described above thatis attached to disc 1702. The prosthesis is illustrated in FIG. 20A in adeployed condition resting on the delivery system with a guidewirepassing through the central lumen of the system and out of the distalend. FIG. 20B illustrates the paddle framework independently of theprosthesis. As illustrated, the framework can simply be a loop ofmetallic or other suitable material that is then attached to theframework of the prosthesis 1700. Markers can be provided along aportion or the entirety of the paddle structure, or the paddle structurecan be formed of radiopaque material, for example, such as 70% NiTi and30% platinum wire, known as “DFT” wire. Moreover, it is preferred toprovide a marker at a radially inward location of the paddle that isdistinct under fluoroscopy, or otherwise at a structural location thatcorresponds directly with the upper extremity of the hole in the lumen(e.g., artery) when the prosthesis is pulled into place. This is becausethe marker, under visualization, is visible to the physician, who willthen be informed when the prosthesis is in the hole (e.g., of theartery), and this even helps the physician “locate” or confirm, thelocation of the hole in the lumen. In short, the marker greatly aids thephysician in correctly positioning the prosthesis in the vessel wall.

FIG. 20C illustrates prosthesis 1700 in a collapsed condition with thepaddle attached to the disc 1702, and further wherein the paddleincludes graft material attached thereto. FIG. 20D illustrates aproximal-distal view of prosthesis mounted on the delivery system,illustrating the proximal face of the proximal disc. FIG. 20E is a sideview of the expanded prosthesis illustrating the positioning of thepaddle attached to the distal disc. FIGS. 20F and 20G further illustrateside views of the prosthesis 1700 particularly illustrating theplacement of graft fabric material on the inner face of each of theproximal and distal discs and between the discs such that the graftmaterial forms a “saddle” shape that presents as a concave projectionwhen viewed from the side that has a minimum diameter near the middle ofthe neck region of the prosthesis 1700 that gradually widens toward eachdisc. This shape of the graft material as supported by the underlyingstructure of the prosthesis is believed to be advantageous in providingan effective seal after implantation, especially with respect to thearterial wall, such as the abdominal aorta. In some embodiments, theprosthesis 1700 is configured so as to not provide a complete seal withrespect to the proximal disc that urges against the inner wall of theinferior vena cava (IVC), for example. In certain instances, completesealing of the IVC of the implant may not be desired. This can be thecase where it is desired for the vein to intake blood that is leakedfrom the corresponding artery that is being sealed by the distal disc.In practice, since the vein may not have significant positive pressure,the need for sealing may be negligible, and it may be advantageous, infact, to maintain some degree of fluid communication between the veinand the space between the vessels via the hole in the vein as a part ofthe procedure.

FIG. 20H illustrates positioning of the delivery system that can beeffected by virtue of the flexible distal portion of intermediatetubular member 118. The flexibility of distal portion of intermediatetubular member 118 can be extremely advantageous as its flexibilitypermits it to be deformed into a geometry that permits it to effectivelybend about 90 degrees with respect to a central axis of a proximalportion of the delivery system, as illustrated in FIG. 20H.Specifically, when implanting the prosthesis 1700 on the arterial side,the paddle is urged against the upper (i.e., cranial) wall above thehole in the artery (e.g., the abdominal aorta) to prevent the prosthesis1700 from being pulled through the hole. However, during this alignmentstep, the paddle urging on the upper, inner wall of the artery canadvantageously be used as a fulcrum, or “pivot point” to rotate theprosthesis into alignment horizontally such that the lower portion ofthe distal disc is also pulled against the inner wall of the artery,below the access hole through which the prosthesis 1700 extends. Thismovement about the “fulcrum” is effectuated by exposing the distal,flexible portion of intermediate tubular member 118 and pushing thedelivery system distally into the vein (e.g., IVC) so that a bowing ofthe intermediate tubular member 118 occurs to obtain a serpentineconfiguration that resembles the shape of a reversed question mark(“?”), as illustrated in FIG. 20 by virtue of the prosthesis 1700 beingconstrained due to partial implantation. This maneuvering pulls theproximal face of the distal disc flush against the arterial wall,completing the implantation of the distal disc, and thus minimizingarterial leakage. It can be particularly advantageous to provide amarker at the base of the paddle where the paddle meets the prosthesisdistal disc, because such a marker, when so positioned, is very usefulfor indicating the location of the arterial hole under fluoroscopybecause the marker is thus located at the “fulcrum” or pivot point,discussed above. Including a fabric on the paddle can provide additionalresistance to pullout of the prosthesis during implantation as the innersurface of the arterial wall can be rough due to plaque formation. Thefabric of the paddle can urge against and somewhat adhere to this unevensurface, facilitating implantation of prosthesis 1700.

FIGS. 21A-E illustrate various stages of deployment of the prosthesiswith respect to the delivery system. FIG. 21A illustrates the prosthesis1700 in a deployed condition with the paddle extending radiallyoutwardly with respect to the prosthesis. As illustrated, the distal tip122 of the outer tubular member can be cut on a bevel to facilitateguiding the device across the wall of the inferior vena cava into theaorta, for example. It is also advantageous to provide a marker band, asillustrated, that is also in an angle at the beveled end of the distaltip 122. Such a marker band is very helpful in alignment of the devicein use, but it also informs the user when the distal tip 122 istraversing the walls of the artery and vein as it is being withdrawnproximally to implant the prosthesis 1700. The net result is that thebeveled end and marker permits superior alignment that helps reducetilting, or canting, of the prosthesis during implantation. This reducedcanting is further aided by the flexibility of the distal end of member118.

FIG. 21B illustrates the prosthesis 1700 in a semi-collapsed state,showing the rotation of the paddle (at upper right) from a radialoutward orientation toward an axial orientation to match the orientationof the proximal face of the distal disc. FIG. 21C shows the prosthesis1700 partially drawn proximally into the distal tip 122 of the deliverycatheter, whereas FIG. 21D shows the prosthesis fully withdrawnproximally into the delivery catheter. Finally, FIG. 21E shows thelateral orientation of the delivery system and prosthesis as it isenvisioned in use during the implantation procedure, with the paddleextending upwardly in an orientation where it can contact the arterialwall above the access opening.

FIG. 22 illustrates placement of the disclosed system in situ in actualuse, wherein the delivery catheter is advanced through the inferior venacava, and the guidewire and prosthesis extend into the abdominal aorta.As illustrated, portion 118 of the delivery system is permitted to flexinto the disclosed reverse question mark shape, facilitating alignmentand placement of the prosthesis 1700 by rotating the prosthesis aboutthe paddle that is urged against the arterial wall above the accessopening into the abdominal aorta. Also pointed out are the location ofthe marker at the base of the paddle, as well as the marker on thebeveled tip 122 of the delivery catheter. As mentioned above, the markerat the base of the paddle (or other marker that could be provided atthat location in other embodiments of prostheses herein) helps thephysician locate the hole in the vessel wall, and to more accuratelyinstall the prosthesis successfully.

In further accordance with the disclosure, embodiments are alsoprovided, but not specifically illustrated, that adds the tetheringfeatures of the embodiments of FIGS. 14-17 to any other embodimentdisclosed herein, including but not limited to the embodiments of any ofFIGS. 1-13, whether or not such embodiments are constructed with aresilient member or coil spring.

In further accordance with the disclosure, any prosthesis disclosedherein can be formed at least in part from a composite wire. In someembodiments, the composite wire can be drawn filled wire. For example,the drawn filled wire can include a first material, and a secondmaterial in a different region of the drawn filled wire that has greaterradiopacity than the first material. The first and second materials caninclude metallic components and/or bioresorbable components. If desired,the second material can be located along a core region of the wire, andfirst material can surround or substantially surround the firstmaterial. The first material can include a NiTi alloy, and the secondmaterial can include platinum, for example. Other suitable examples formaking such composite materials can be found in U.S. patent applicationSer. No. 10/524,387, filed Sep. 13, 2004, which is incorporated byreference herein in its entirety for any purpose whatsoever.

The devices disclosed herein can be implanted via the delivery system intransmural or transcameral applications using techniques similar tothose presented in International Patent Application No.PCT/US2013/072344, filed Nov. 27, 2013 and published Feb. 12, 2015 asWO/2015/020682 A1, which is incorporated by reference herein in itsentirety for any purpose whatsoever. However, the presently disclosedembodiments permit easier deployment, adjustment, and retrievability byvirtue of the elastic member and pushrod, among other things.

Thus, an exemplary method for use of any of the devices herein can be inconjunction with a method of transcatheter delivery of a device to thecardiovascular system. The method can include advancing a puncturedevice through a femoral vein to a venous crossing site, the venouscrossing site being located along an iliac vein or the inferior venacava. The method can further include using the puncture device topuncture a venous wall at the venous crossing site and then puncture anadjacent arterial wall at an arterial crossing site. The arterialcrossing site is preferably located along an iliac artery or theabdominal aorta. The method can further include advancing at least aportion of the puncture device into the iliac artery or the abdominalaorta, thereby forming an access tract between the venous crossing siteand the arterial crossing site.

The method can further include advancing a catheter through the accesstract from the venous crossing site to the arterial crossing site, anddelivering the device into the iliac artery or the abdominal aortathrough the catheter. The device can be a prosthetic heart valve, aorticendograft, left ventricular assist device, or cardiopulmonary bypassdevice among other potential devices. In some embodiments, the puncturedevice can be selectively electrically energized to puncture the venouswall and the arterial wall. The puncture device can include inner andouter coaxial members, wherein the inner member comprises a guide wireor needle that is advanced to initially puncture the venous and arterialwalls, and the outer member can be advanced over the inner member toenlarge the initial punctures and facilitate introduction of largerdevices through the access tract. A target device can be advancedthrough a peripheral artery to adjacent the arterial crossing site. Thetarget device can be used to guide an operator in directing the path ofthe puncture device through the arterial wall and into the iliac arteryor the abdominal aorta.

After the access tract is formed, a guidewire can be introduced throughthe access tract. The catheter can then be advanced over the guidewirethrough the access tract into the iliac artery or the abdominal aorta todeliver the device. After delivering the device, an occlusion device asdescribed herein can be delivered over a guidewire into the access tractto close the access tract. The occlusion device is preferably radiallycompressible for transcatheter delivery and radially expandable forimplantation. The occlusion device can include an arterial portion forplacement at the arterial crossing site, a venous portion for placementat the venous crossing site, and a neck portion for placement in theaccess tract. The occlusion device can include a guidewire channelextending through the venous portion, the neck portion, and the arterialportion. This portion of the procedure can be implemented by deploying adelivery catheter as disclosed herein and advancing it into the arteryand deploying a first portion, such as a lobe or disc, of the prosthesisinto the artery, optionally deploying one or more discs between theartery and vein, and deploying a disc or lobe into the vein. If theprosthesis includes a spring as described herein or tethers, the devicecan be collapsed by pushing on the push rod to partially collapse theprosthesis to permit it to be repositioned and redeployed, or fullycollapsed and withdrawn back into the delivery system. The implant ispreferably configured to be implanted across an arteriovenous fistula ortract connection between an artery and a vein with the arterial endportion positioned in the artery, wherein the venous end portion ispositioned in the vein, and a neck portion is positioned in the fistulaor tract connection.

The systems disclosed herein can be used to close congenital heartdefects including atrial septal defect, ventricular septal defect,persistently patent ductus arteriosus. The system can be used to closediatrogenic heart defects including extra-anatomic vascular access portsfrom the chest across the wall of the left or right ventricle into therespective lumen, or from the chest across the wall of the left or rightatrium into the respective lumen, both to achieve temporarytranscatheter access to the heart to allow therapeutic catheterinterventional procedures or implantation such as mitral valve ortricuspid valve or aortic valve or pulmonic valve or prosthesis orannuloplasty implantation or modification or repair of Paravalvularleaks.

All statements herein reciting principles, aspects, and embodiments ofthe invention, as well as specific examples thereof, are intended toencompass both structural and functional equivalents thereof.Additionally, it is intended that such equivalents include bothcurrently known equivalents as well as equivalents developed in thefuture, i.e., any elements developed that perform the same function,regardless of structure.

The methods and systems of the present disclosure, as described aboveand shown in the drawings, provide for improved techniques for treatinglumenal systems of patients. It will be apparent to those skilled in theart that various modifications and variations can be made in thedevices, methods and systems of the present disclosure without departingfrom the spirit or scope of the disclosure. Thus, it is intended thatthe present disclosure include modifications and variations that arewithin the scope of the subject disclosure and equivalents.

What is claimed is:
 1. A system for delivering a deformable prosthesis,comprising: a) an outer tubular sheath having a proximal end and adistal end and defining a first lumen therethrough along at least aportion of its length; b) an intermediate tubular member disposed atleast partially within the first lumen and being slidably disposed withrespect to the outer tubular sheath, the intermediate tubular memberhaving a proximal end, a distal end, and, a flexible distal portionconfigured to be protrudable distally beyond the distal end of the outertubular sheath, the intermediate tubular member defining a second lumentherethrough along at least a part of its length; c) an inner elongatemember being disposed at least partially within the second lumen, theinner elongate member being slidably disposed with respect to theintermediate tubular member, the inner elongate member having a proximalend and a distal end configured to be displaced distally beyond thedistal end of the intermediate tubular member; and d) a prosthesisremovably mounted on the distal end of the intermediate tubular member,wherein the prosthesis can be longitudinally stretched by advancing theinner elongate member distally with respect to the intermediate tubularmember and against an inner face of an end region of the prosthesis, andfurther wherein said longitudinal stretch of said prosthesis causes theprosthesis to collapse radially inwardly to permit said prosthesis to bewithdrawn into said distal end of said outer tubular sheath.
 2. Thesystem of claim 1, wherein the distal end of the outer tubular member iscut at an angle that is oblique with respect to a central axis definedby the system.
 3. The system of claim 2, wherein the distal end furtherincludes a radiopaque marker proximate the distal end making the angleat which the distal end is cut being visible under fluoroscopy to helpreduce canting of the prosthesis during implantation.
 4. The system ofclaim 1, wherein the flexible of distal portion of the intermediatetubular member is configured and adapted to permit the intermediatetubular member to be deformed into a reverse curved geometry withrespect to a central axis of a proximal portion of the delivery systemwhile inside a patient's lumen.
 5. The system of claim 1, wherein theinner elongate member is a tubular member configured to permit aguidewire to pass therethrough.
 6. The system of claim 5, wherein thedistal end of the inner elongate member is configured to abut againstthe inner face of the end region of the prosthesis to form a guidewirelumen to permit the guidewire passing through the inner elongate memberto pass through a distal face of the prosthesis.
 7. A method,comprising: a) providing a delivery system having a prosthesis removablyattached to a distal end thereof; b) delivering the delivery system overa guidewire routed to a target location within a patient's vasculature;c) deploying the prosthesis at the target location to obstruct avascular opening to be sealed; d) detaching the prosthesis from thedelivery system; e) withdrawing the delivery system over the guidewireafter the prosthesis has been detached therefrom; f) advancing thedelivery system toward the target location over the guidewire after thewithdrawing step; g) reattaching the prosthesis to the delivery system;and h) performing a further step with the prosthesis.
 8. The method ofclaim 7, further comprising partially collapsing the prosthesis afterthe deploying step.
 9. The method of claim 7, further comprising atleast partially repositioning the prosthesis after the deploying step.10. The method of claim 7, further comprising at least partiallyrepositioning the prosthesis after the detaching step.
 11. The method ofclaim 7, further comprising collapsing and withdrawing the prosthesisinto the delivery system.
 12. The method of claim 7, further comprisingwithdrawing the delivery system with the prosthesis attached theretoover the guidewire.
 13. A method, comprising: a) providing a deliverysystem having a prosthesis removably attached to a distal end thereof,the prosthesis being configured to radially self-expand into at leasttwo axially spaced discs; b) delivering the delivery system over aguidewire routed to a target location within a patient's vasculature; c)deploying a first of said at least two discs proximate a first side of afirst wall of an anatomical structure next to a vascular opening to besealed; d) deploying a second of said at least two discs proximate asecond side of the first wall of the anatomical structure the prosthesisat the target location to obstruct the vascular opening; e) applyingtension to at least one tether routed through said at least two axiallyspaced discs to cause the prosthesis to collapse axially.
 14. The methodof claim 13, wherein tension is applied to the at least one tether untilleaks through the vascular opening are stopped.
 15. The method of claim13, further comprising securing the at least one tether.
 16. The methodof claim 15, wherein the at least one tether is secured by tying it off17. The method of claim 15, wherein the at least one tether is securedby applying at least one clip to it.